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Update on March 3, 2023: Study EAA171 is now closed to patient enrollment.
Researchers at the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) are leading three clinical trials that explore possible new treatments for adults with multiple myeloma or at high risk of developing the disease. Myeloma is uncommon in the United States, representing 1.8% of all new cancer cases and 2.1% of all cancer deaths in 2022 (SEER database). A person’s risk of developing this cancer in their lifetime is 0.8%. However, for individuals who are affected, the estimated five-year relative survival rate is 57.9% (2012-2018).
The three studies below all aim to improve outcomes for patients dealing with this disease currently or at high risk of developing myeloma.
EAA181 – Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
The study chair for this trial is Shaji Kumar, MD (Mayo Clinic). The study co-chairs are Lale Kostakoglu, MD, MPH (University of Virginia/UVA Cancer Center), and Matthias Weiss, MD (ThedaCare Regional Cancer Center).
The standard initial therapy for patients with newly diagnosed multiple myeloma is treatment with the three-drug combination of lenalidomide, dexamethasone, and either bortezomib (VRd) or daratumumab (DRd). The latter combination is especially utilized for patients considered ineligible for stem cell transplant (SCT) or not wishing to proceed to an early SCT. The purpose of this randomized phase 3 study is to determine if there is any benefit to the use of all four drug classes in a combined quadruplet regimen as initial therapy. The trial will also identify if that benefit is dependent upon the degree of response achieved during induction.
This study aims to enroll 1450 patients.
Learn more about the EQUATE trial and view the eligibility criteria.
EAA173 – Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
The study chair for this trial is Natalie Callander, MD (University of Wisconsin/UW Carbone Cancer Center). The study co-chairs are Sagar Lonial, MD (Emory University/Winship Cancer Institute), Lale Kostakoglu, MD, MPH (University of Virginia/UVA Cancer Center), and Matthias Weiss, MD (ThedaCare Regional Cancer Center).
The usual course of action for patients with smoldering multiple myeloma (SMM), a precancerous condition, is observation until symptoms appear. Multiple factors can be used to identify individuals with SMM who are at greatest risk of developing symptomatic multiple myeloma. Emerging data suggests that early intervention in these patients may alter or at least delay this progression. This randomized phase 3 trial for patients with SMM and high-risk features aims to improve upon the current treatment approach (induction therapy with lenalidomide and dexamethasone (Rd) followed by maintenance lenalidomide) by adding the monoclonal antibody daratumumab to induction therapy.
Learn more about the DETER-SMM trial and view the eligibility criteria.
EAA171 – Optimizing Prolonged Treatment In Myeloma Using MRD Assessment (OPTIMUM)
The study chair for this trial is Shaji Kumar, MD (Mayo Clinic). The study co-chairs are Ajay Nooka, MD, MPH (Emory University/Winship Cancer Institute), Lale Kostakoglu, MD, MPH (University of Virginia/UVA Cancer Center), and Matthias Weiss, MD (ThedaCare Regional Cancer Center).
This randomized phase 3 trial is for patients with multiple myeloma who have undergone an autologous stem cell transplant and are on lenalidomide maintenance chemotherapy. The study focuses on a subgroup of patients who have measurable or minimal residual disease (MRD) remaining in the body despite these treatments. Researchers hypothesize that the survival of this group of patients may be improved by adding ixazomib, an oral proteasome inhibitor, to lenalidomide maintenance therapy versus lenalidomide alone.
Learn more about the OPTIMUM trial.